Safety Issues About Nevirapine Administration in HIV-Infected Pregnant Women

Abstract

Nevirapine represents an effective and well-tolerated nonnucleoside reverse transcriptase inhibitor (NNRTI) that is broadly available to prevent vertical HIV transmission in resource-poor populations. Even after its removal from firstline antiretroviral drugs for drug-naive patients nevirapine is widely and safely used in simplification regimens. The latest guidelines for antiretroviral therapy (updated on October 10 20061) also state that nevirapine pharmacokinetics are not significantly affected by pregnancy such that no dosage change is indicated in this condition. Unfortunately although nevirapine has not been shown to cause fetal malformations some reports point out that women whose CD4+ counts are greater than 250 cells/mL when they first initiate therapy may face an increased risk of potentially fatal liver toxicity which is often associated with rash. A 2005 warning from the US Food and Drug Administration (FDA) recommended maximum attention on a possible increase of nevirapine liver toxicity among HIV-infected women with CD4+ counts >250 cells/mL especially during pregnancy. (excerpt)